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Laser Thermal Therapy Kit S E
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref EI KT0 0011 001
by ELESTA SpA
Identity
- Trade Name
- Laser Thermal Therapy Kit S E EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Laser Thermal Therapy Kit S E EUDAMEDThe LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272micron core quartz-quartz fiber with distal end outer diameter 420micron and NA 0.2) and an introducer needle (21G). The device is sterile and single use. FDA UDI
- Model / Reference
- EI KT0 0011 001 EUDAMEDFDA UDI
- Description
- The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272micron core quartz-quartz fiber with distal end outer diameter 420micron and NA 0.2) and an introducer needle (21G). The device is sterile and single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052286590500 EUDAMED08052286590210 FDA UDI
- Basic UDI-DI
- 805228659EIKT00011xxx5H EUDAMED
- 510(k) Number
- K230460 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Medical Purpose
- The Laser Thermal Therapy Kit is used to direct laser energy to soft tissues in image-guided endoscopic and percutaneous laser thermal ablation procedure. The energy is transmitted via the fiber optic, which is introduced into the tissue using the introducer needle. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Laser Thermal Therapy Kit S E by Elesta Spa — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260632 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230460 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805228659EIKT00011xxx5H | Class IIa | Active |
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Manufacturer
- Manufacturer
- ELESTA SpA
- EUDAMED SRN
- IT-PR-000040697
Sources (3)
- EUDAMED c0506140-5f59-4874-a78f-18fff2297395 61 fields · synced Jul 25, 2026
- FDA UDI e3d55835-3bc0-4ccb-a393-94e0fe8dfb96 34 fields · synced May 30, 2026
- FDA 510(k) K260632 1 fields · synced May 18, 2026